ASCO 2009:罹患進展性大腸直腸癌可能不需要預先開刀


  June 1, 2009(佛州奧蘭多)-根據發表在美國臨床腫瘤醫學會(ASCO)第45屆年會的數據,大部分罹患轉移性大腸直腸癌患者可以安全地不用對原發腫瘤開刀。無症狀外科手術無法治癒的大腸直腸癌並不需要立即進行手術移除腫瘤,直到他們出現併發症為止。
  
  主要研究者、紐約市Sloan-Kettering紀念癌症中心外科主治醫師與臨床研究副主任Philip Paty醫師表示,有同步轉移大腸直腸癌患者,進行原發腫瘤切除的好處並不清楚;但是即使沒有改善存活率的證據,這樣的手術確實經常進行。原理是這可以避免之後的併發症,例如出血、穿孔或是阻塞。
  
  在確診時以外科手術移除原發性腫瘤,對於轉移性大腸直腸癌患者仍然是很常見的,但是隨著新的、更有效的化學治療藥物的發明,是否仍然進行手術,目前仍不清楚。
  
  在這項研究中,Paty醫師與其同事們想要確認,接受目前當代合併化學治療但未進行預防性手術的同步第五期大腸直腸癌患者,發生併發症的機率。
  
  這項回溯性研究於Sloan-Kettering紀念癌症中心進行。使用一個前瞻性的機構資料庫,研究者們找出233位從2000年到2006年罹患轉移性大腸直腸癌,以及未經切除之原發性腫瘤的連續患者。這些患者也接受oxaliplatin或是irinotecan為主的三重化學治療(FOLFOX、IFL或是FOLFIRI)加上或是未加上bevacizumab(Avastin)作為他們的起始治療。之後接受手術、放射線治療、以及/或是腔內支架置放來處理原發性腫瘤的病患。
  
  在233位病患中,絕大部分(217位或是93%)從未接受外科手術緩和治療他們的原發性腫瘤。Paty醫師表示,10位病患發生阻塞,但未經手術治療,舉例來說,接受支架放置或是放射線治療。
  
  16位病患接受緊急手術來排除原發性腫瘤阻塞或是穿孔,而47位病患最終在轉移腫瘤切除時接受選擇性大腸切除。另外8位病患在進行肝臟動脈輸注幫浦放置開腹手術時,接受選擇性大腸切除。
  
  研究者們表示,使用bevacizumab、直腸原發性腫瘤的位置、轉移疾病嚴重度並未與介入機率上升有關。其次,是否需要進行緊急介入與整體存活並無關係。
  
  Paty醫師表示,我們觀察到93%從未接受大腸手術來治療原發性腫瘤造成的併發症。
  
  他解釋,這些現在在他們的機構是常規規範,但事前手術仍然是個人化的選擇;我們的研究並非革命性的,許多外科醫師正在進行這項政策,但是並沒有很多發表的數據。
  
  由Medscape腫瘤學聯繫提供獨立評論的Nicholas Petrelli醫師表示,這種治療方式有兩種重要的好處。
  
  美國德拉威州威明頓Helen F. Graham癌症中心醫療主任Petrelli醫師表示,你可以快點開始進行化學治療,且病患們可以免於手術。我認為Paty醫師的研究確實是項重要發現。
  
  Petrelli醫師強調,這需要更多研究數據,且NSABP-C-10─一項第二期臨床研究,為了要評估接受化學治療而非事前治療移除原發腫瘤的族群,可能會提供更多的研究。
  
  Petrelli醫師表示,我們幾乎已經完成完整的病患收納,而那項研究的數據將可以支持這是否應該成為標準照護。
  
  Paty醫師與Petrelli醫師表示沒有相關資金上的往來。共同作者Leonard Saltz與Nancy Kemeny表示接受來自輝瑞、Genetech、賽諾菲安萬特、必治妥、安進與Imclone公司的諮詢/顧問費用。
  

ASCO 2009: Patients With Advanced Colorectal Cancer May Not Need Upfront Surgery

By Roxanne Nelson
Medscape Medical News

June 1, 2009 (Orlando, Florida) — Most patients with metastatic colorectal cancer can safely avoid surgery on their primary tumors. According to data presented here at the American Society of Clinical Oncology (ASCO) 45th Annual Meeting, patients with asymptomatic surgically incurable colorectal cancer do not need immediate surgery to remove their tumor unless they are having complications.

Primary tumor resection in patients who present with synchronous metastatic colorectal cancer is of uncertain benefit. "But even though there is no proven benefit for survival, such operations are frequently done," said lead author Philip Paty, MD, an attending surgeon and vice chair of clinical research at Memorial Sloan-Kettering Cancer Center in New York City. "The rational is that it prevents future complications, such as bleeding, perforation, or obstruction."

Surgical removal of the primary tumor at the time of diagnosis is still common in patients with metastatic colorectal cancer, but with the advent of new and more effective chemotherapeutic agents, it is unclear whether surgery is still warranted.

In this study, Dr. Paty and colleagues sought to determine the frequency of complications in patients with synchronous stage?IV colorectal cancer who received up-front modern combination chemotherapy without prophylactic surgery.

The retrospective study was conducted at Memorial Sloan-Kettering. Using a prospective institutional database, the researchers identified 233 consecutive patients from 2000 to 2006 with synchronous metastatic colorectal cancer and an unresected primary tumor. The patients in this group also received oxaliplatin- or irinotecan-based triple-drug chemotherapy (FOLFOX, IFL, or FOLFIRI) with or without bevacizumab (Avastin) as their initial treatment. Patients who underwent subsequent surgery, radiotherapy, and/or endoluminal stenting to manage primary tumor complications were then identified.

Of 233 patients, the vast majority (217 or 93%) never required surgical palliation of their primary tumor. "Ten patients developed an obstruction but were treated without surgery, [for example, with] a stent or radiation," said Dr. Paty.

Sixteen patients did require emergency surgery for primary tumor obstruction or perforation, and 47 patients eventually underwent an elective colon resection at the time of metastasectomy. An additional 8 patients had an elective colon resection during a laparotomy for hepatic artery infusion-pump placement.

The researchers noted that the use of bevacizumab, the location of the primary tumor in the rectum, and the metastatic disease burden were not associated with an increased rate of intervention. Also, the necessity of emergency intervention did not correlate with overall survival.

"We observed that 93% never required colon surgery to treat complications from the primary tumor," said Dr. Paty.

This is now the routine practice at his institution, he explained, but there is still individualized selection for up-front surgery. "Our study is not revolutionary, in that many surgeons are practicing this policy, but there is just not a lot of published data."

There are 2 important advantages to this practice, said Nicholas Petrelli, MD, who was approached by Medscape Oncology for an independent comment.

"You can start chemotherapy sooner and the patient avoids having to undergo surgery," said Dr. Petrelli, medical director of the Helen F. Graham Cancer Center in Wilmington, Delaware. "I think that Dr. Paty is onto something."

Dr. Petrelli emphasized that more data are needed, and noted that the results of NSABP-C-10, a phase?2 trial designed to evaluate the treatment of this population with chemotherapy rather than up-front therapy to remove the primary tumor, may provide such data.

"We have almost completed patient accrual," said Dr. Petrelli, "and the results of that trial will support whether or not this should become the standard of care."

Dr. Paty and Dr. Petrelli have disclosed no relevant financial relationships. Coauthors Leonard Saltz and Nancy Kemeny report having a consulting/advisory role or receiving research funding from Pfizer, Genentech, Sanofi-Aventis, Bristol Myers, Amgen, and Imclone.

American Society of Clinical Oncology (ASCO) 45th Annual Meeting: Abstract CRA4030. Presented June 1, 2009.

    
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